Glucose and Insulin Responses to Test Foods

Mondelez International

Status: Completed

Conditions: Insulin Response; Glucose Response

Treatments: Other: Test Food 1 (Cereal); Other: Reference Glucose; Other: Test Food 2 (Biscuit)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01671878

GIl1244

Details and patient eligibility

About

In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male & half female, and half normal weight (BMI > 19.0 and < 25.0) and half overweight but not obese (BMI > 25.0 and < 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include:
• Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose < 5.6 mmol/L (100 mg/dL) AND plasma glucose levels < 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit)
• Systolic blood pressure 100-150 mmHg inclusive
• Diastolic blood pressure 60-90 mmHg inclusive
• Resting heart rate 50-90 beats/min inclusive after 3 minute rest
• Able to refrain from eating legumes and drinking alcohol the day before each test session
• Fasting triglycerides < 2.0 mmol/L (178 mg/dL)
• Fasting HDL cholesterol > 0.9 mmol/L (35 mg/dL) for males and > 1.1mmol/L (42 mg/dL) for females
• Fasting LDL cholesterol < 5.0 mmol/L (193 mg/dL)
• AST and ALT < 120% of upper limit of normal (ULN)
• hsCRP < 10 mg/L
• Urea and creatinine < 150% ULN

Exclusion criteria

• failure to meet any one of the inclusion criteria
• age less than 18 or over 45 years
• known history or AIDS, hepatitis, diabetes or a heart condition
• participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
• participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines.
• Food allergies of any kind
• General anaesthesia in the month prior to inclusion.
• Smokers

Trial design

12 participants in 3 patient groups

Reference Glucose

Other group

Description:

Glucose standard

Treatment:

Other: Reference Glucose

Test Food 1

Experimental group

Description:

Cereal

Treatment:

Other: Test Food 1 (Cereal)

Test Food 2

Experimental group

Description:

Biscuit

Treatment:

Other: Test Food 2 (Biscuit)